In recent years, attempts to identify new biomarkers to replace the current diagnostic techniques and follow-up activities in the field of oncology have favored the transition to personalised medicine ‘to cure the right patient at the right time, with the right dose of the right drug’.

The circulating microRNAs are considered good bio-marking candidates thanks to the association with certain cancer pathologies and to resistance at degradation, PH variations and temperature modification.

Nowadays, only specialized research and analysis centres due to the high costs and complexity of use can use the circulating microRNAs detection technologies.

To ensure the transition from “bench” to “bedside” is necessary a low-cost technology for microRNA detection that can be widely disseminated in the hospitals as well as in the whole territory.

The point of care (POC) is the most known and used analysis system in the current clinical practice. The rising uses of these devices have a positive effect on the national healthcare system budget with the reducing of the expensive analysis activities.

The technology of lateral flow-based POC systems allows the spotting and production techniques for the analysis of nucleic acids in appropriately engineered supports.

The current absence of specific tests for circulating microRNAs detection is a new market opportunity for a rapid test.

The design idea of SERMI4Cancer involves the development of a POC system integrated with the innovative SERS (Surface-Enhanced Raman Spectroscopy) technology for the detection of circulating microRNAs. Using the low-cost, portable and user-friendly technology makes it possible to detect the chemical composition of complex biological samples, such as blood or serum.

The RamanSERS spectrum like molecular fingerprint can be used in many fields of medicine.

Thanks to the high chemical specificity is possible a direct detection of the circulating microRNAs without a particular staining or marking methods of the analyte, these characteristics makes this technology a suitable integration for the POC system.

The R&D activity will be developed in a pilot project in the hematology field. During the project the pathological progression will be analyzed; starting from the preneoplastic conditions till the development of hepatocellular carcinoma will be considered. This type of cancer disease represents the world's second cancer mortality rate and its incidence is estimated to increase over the next years.

The ultimate goal of the project is to produce a rapid point of care test prototype for measuring circulating microRNAs in liver cancer patients and predisposing chronic pathologies. The project envisages the development of 3 components that will form an integrated POC-SERS system:

  • The microRNA separation and binding support (polyfunctional matrix strip);
  • The detection system consists of SERS (Surface Enhanced Raman Spectroscopy) RAMAN spectrophotometer and a SOST nanostructured sensor, integrated with innovative support developed during the project.

Figure 1. The collection system, data analysis and integration of clinical and molecular data (telematic management software).

As defined in the current National Oncology Plan, ones of the targets is to increase the survival of oncologic patients by monitoring the at-risk population and preventing complications and recurrences as well as reducing costs by taking appropriate measures and using technological innovation.

Starting from a simple blood sampling it will be possible to read the data through a Raman spectrometer, and then process and transfer it via a dedicated computer platform. The point of care will be a useful device to monitor the patients inside and outside the hospital, and the territorial integration of this management platform will be useful for the patients care services network implementation. 

The development of this system will ensure a more efficient and effective management of liver pathologies, improve the therapeutic pathway and reduce the complications as well as management costs.


 

S3 Specialization Area:
Smart Health

Topic:

Biomedical, Diagnonistic in vivo and vitro, innovative therapy


Starting date: 22/05/2017

End date: 21/05/2019


Total project: € 1.210.312,26

Total grant: € 886.493,75

 

Brochure591.38 KB
Poster596.25 KB

Partner

Dott. Dino Paladin

The Dott. Dino Paladin Company operates in the following sectors:

- Development and pilot production of biotechnology and nanotechnology products, particularly the development and patenting of drugs currently in production by another company; it has collaborated in research contract projects to develop more than 100 medical-diagnostic devices in-vitro labelled CE (CE IVD) in molecular biology.

Production, installation, repair and maintenance of medical instruments and software for:

  • molecular diagnosis;
  • devices for analysis and research;
  • tracing of workflow and samples in pathological anatomies;
  • development of products for the realisation and management of biobanks.
  • The company has solid research-and-development (R&D) experience in the field of human diagnostics, having collaborated with various universities in the study of tumour drug resistance, HLA typing, genetic diseases and viral typing to acquire and consolidate knowledge for avant-garde molecular biology techniques.
     

Dott. Dino Paladin
Statale 14 km 169,5
AREA Science Park Basovizza, Edificio Q1
34149 TS
Italy

Università degli Studi di Trieste - Dipartimento di Ingegneria ed Architettura – Project Partner

In compliance with its mission, the Engineering and Architecture Department (DIA) of the University of Trieste prepares highly professional individuals and provides technical-scientific support to the economy of a large territory, whose backbone is composed of large international companies, a network of medium and small businesses and an infra-structural system with several transport and logistics companies.

Thanks to its wide and rich range of skills, the University offers didactic activities, scientific research, technology transfer and knowledge, as well as four three-year degree courses, nine specialised degree courses and a one-cycle degree course in Architecture.

The Department’s activities concern numerous research areas and are conducted in various sectors, including energy, the environment, process and product analysis, information and communication technologies and biomedical applications, in which the involved research group operates with proven skills in the field of Raman and SERS spectroscopy.
 

Università degli Studi di Trieste - Dipartimento di Ingegneria ed Architettura – Project Partner
Piazzale Europa,1
34132 TS
Italy

Fondazione Italiana Fegato

The Fund for Liver Diseases - Fondo per le Malattie del Fegato (founded in 1989) founded the Italian Liver Foundation - Fondazione Italiana Fegato ONLUS (FIF) in 2008. The FIF was the first Italian institution to combine basic research and clinical activity in the field of liver disease. The main purpose of the FIF is promoting translational research to bring the results of molecular research into clinical practice. Furthermore, FIF provides an intensive educational support by hosting many students and researchers from all over the world.

The Italian Liver Foundation finances its activities with institutional funds from its public and private partners and with ad hoc funding for research projects. Currently, the FIF staff is composed of three senior researchers, one administrative secretary, one laboratory technician, six post-doctoral researchers and two graduate students.

The FIF boasts numerous collaborations with research institutions and hospitals at the national and international levels, including the University of Ljubljana; the University of Prague; Fundación Favaloro; Buenos Aires and Centro Binacional de Criobiología Clínica y Aplicada, Rosario (Argentina); Universidad National Autonoma Mexico City (DF Mexico); the Eijkman Institute for Molecular Biology and Medicine, Jakarta (Indonesia); The Children Mercy Hospital, Kansas City (USA).
 

Fondazione Italiana Fegato
S.s. 14 km 163.5
34149 TS
Italy

Alphagenics Biotech S.r.l.

Alphagenics is one of the most qualified national companies in the use of innovative molecular biology techniques, suitable both for clinical use and research in the medical and environmental fields, for the in-depth analysis of prognostic/diagnostic issues.

Aphagenics focuses on the research, development and production of testing kits. The company provides consulting services for the technology transfer of new projects, and its R&D department is engaged in the development of new technologies and the design of custom solutions to fully meet the market’s needs. The company has developed different systems for the molecular typing and quantification of viral genomes (HPV/HCV) using reverse dot/blot, real-time PCR and ELISA methodologies. The company also offers a full panel of prognostic kits, based mainly on real-time PCR technology, for some of the most important cancers, such as kits for colon and gastric carcinoma (ARKRAS e ACMSi), thyroid, colon and melanoma cancer (ARBRAF), glioblastoma (ARMGMt), lung cancer (A lEGFR) and an innovative prognostic kit that provides the probability of breast cancer recurrence (ARBREASt). Tests are highly reproducible, sensitive and rapid.

Alphagenics Biotech S.r.l.
s.s. 14 km 163.5
34149 TS
Italy

Insiel Mercato Spa

Insiel Mercato develops e-health and e-government solutions that enable healthcare and public administration organisations to offer the best services to the communities in which they operate, enabling citizens to become leaders in exercising their rights. With over 1,000 customers and more than 200 employees, Insiel Market is a leading company in Italy’s IT sector.

Insiel Mercato Sp.a
Padriciano, 99
34149 TS
Italy